Corticosteroids and Anti TNF in Methotrexate Inadequate Responder Rheumatoid Arthritis Patient
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01724268|
Recruitment Status : Unknown
Verified November 2012 by Hamad Medical Corporation.
Recruitment status was: Recruiting
First Posted : November 9, 2012
Last Update Posted : November 9, 2012
Compare the efficacy of adding small doses of prednisolone (10 mg) daily to the efficacy of adding one of the available anti TNF in the treatment of methotrexate inadequate responder rheumatoid arthritis patient.
Methotrexate + Prednisolone vs. Methotrexate + anti TNF
|Condition or disease||Intervention/treatment||Phase|
|RHEUMATOID ARTHRITIS||Drug: Pred + Meth Drug: Anti TNF + Meth||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Randomized Controlled Clinical Trial of Low Dose Corticosteroids vs Anti TNF Treatment in Methotrexate Inadequate Responder Rheumatoid Arthritis Patient- a Pilot Study|
|Study Start Date :||May 2012|
|Estimated Primary Completion Date :||May 2014|
|Estimated Study Completion Date :||September 2014|
Experimental: Pred + Meth
Prednisolone : 10 mg daily
+ Methotrexate : 25 mg/ day
ARM 1 Treatment Arm
Drug: Pred + Meth
PREDNISOLONE 10mg orally ONCE DAILY and Methotrexate 25 mg / day
Active Comparator: Anti TNF + Meth
Etanrcept: 50 mg; Adalimumab: 40 mg; Infliximab: 3mg/kg
+ Methotrexate 25 mg per day Control Arm
Drug: Anti TNF + Meth
- Disease activity score [ Time Frame: 4 months ]DAS 28: Disease activity score, is a modification of the original DAS score, it divides disease activity into high, moderate, low disease activity, and remission (High disease activity is DAS28 >5.1, moderate is DAS28 of >3.2 to 5.1, low disease activity is DAS28 of 2.6 to 3.2, and remission is DAS28 <2.6).
- HAQ Score [ Time Frame: 4 months ]HAQ Score: Health Assessment Questionnaire evaluates patients' ability to perform activities of daily living through their answers to 20 questions designed to assess upper or lower extremity use. These questions are organized into eight categories: dressing, rising, eating, walking, hygiene, reach, grip, and usual activities. Each question is answered on a four-level scale of impairment ranging from 0 to 3: 0 = no difficulty; 1 = some difficulty; 2 = much difficulty; and 3 = inability to do.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01724268
|Hamad General Hospital||Recruiting|
|Doha, Ad Dawha, Qatar, 3050|
|Contact: MAGDI H ABDELRAHMAN, MBBS email@example.com|
|Principal Investigator:||MAGDI H ABDELRAHMAN, MBBS||Hamad Medical Corporation|
|Principal Investigator:||MOHAMMED M HAMMOUDEH, MD||Hamad Medical Corporation|